This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the post-approval study protocol.
| Device | XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2013-04-08 |
| Decision Date | 2013-06-07 |
| PMA | P070015 |
| Supplement | S108 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 26531 Ynez Road, Building G p.o.box 9018 temecula, CA 92589-9018 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070015 | Original Filing | |
| S148 | 2021-02-22 | 30-day Notice |
| S147 | 2020-02-13 | 30-day Notice |
| S146 | 2019-09-26 | 135 Review Track For 30-day Notice |
| S145 | 2019-06-12 | 30-day Notice |
| S144 | 2019-01-24 | 30-day Notice |
| S143 | 2018-09-05 | 30-day Notice |
| S142 | 2018-03-23 | 30-day Notice |
| S141 | 2018-03-01 | Normal 180 Day Track |
| S140 | 2018-01-26 | 30-day Notice |
| S139 | 2017-12-11 | Normal 180 Day Track No User Fee |
| S138 | 2017-09-28 | 135 Review Track For 30-day Notice |
| S137 | 2017-05-17 | 30-day Notice |
| S136 | 2017-04-05 | 30-day Notice |
| S135 | 2016-11-23 | 30-day Notice |
| S134 | 2016-09-12 | 135 Review Track For 30-day Notice |
| S133 | 2016-07-08 | Normal 180 Day Track No User Fee |
| S132 | 2015-11-16 | 135 Review Track For 30-day Notice |
| S131 | 2015-09-25 | 30-day Notice |
| S130 | ||
| S129 | ||
| S128 | 2015-02-02 | Panel Track |
| S127 | 2015-01-14 | 30-day Notice |
| S126 | 2014-09-26 | 30-day Notice |
| S125 | 2014-09-25 | 30-day Notice |
| S124 | 2014-08-27 | 30-day Notice |
| S123 | 2014-04-14 | 30-day Notice |
| S122 | 2014-03-21 | Panel Track |
| S121 | 2014-03-18 | 30-day Notice |
| S120 | 2014-02-10 | 30-day Notice |
| S119 | 2013-12-23 | 135 Review Track For 30-day Notice |
| S118 | 2013-12-12 | 30-day Notice |
| S117 | 2013-11-27 | Normal 180 Day Track No User Fee |
| S116 | 2013-10-24 | 30-day Notice |
| S115 | 2013-10-18 | 30-day Notice |
| S114 | 2013-09-30 | 30-day Notice |
| S113 | 2013-07-29 | 30-day Notice |
| S112 | 2013-05-31 | 30-day Notice |
| S111 | 2013-05-17 | 135 Review Track For 30-day Notice |
| S110 | 2013-05-14 | 30-day Notice |
| S109 | 2013-04-30 | Normal 180 Day Track No User Fee |
| S108 | 2013-04-08 | Normal 180 Day Track No User Fee |
| S107 | 2013-04-02 | Normal 180 Day Track |
| S106 | 2013-01-22 | 30-day Notice |
| S105 | ||
| S104 | 2012-11-09 | 30-day Notice |
| S103 | ||
| S102 | 2012-10-02 | 30-day Notice |
| S101 | 2012-09-28 | 30-day Notice |
| S100 | ||
| S099 | 2012-08-13 | 30-day Notice |
| S098 | 2012-07-30 | 30-day Notice |
| S097 | 2012-07-20 | 30-day Notice |
| S096 | 2012-06-11 | 30-day Notice |
| S095 | ||
| S094 | 2012-06-19 | Normal 180 Day Track |
| S093 | 2012-05-14 | 135 Review Track For 30-day Notice |
| S092 | 2012-03-12 | Normal 180 Day Track No User Fee |
| S091 | 2012-02-23 | 30-day Notice |
| S090 | 2012-02-06 | 30-day Notice |
| S089 | 2012-02-03 | 30-day Notice |
| S088 | 2012-02-01 | 135 Review Track For 30-day Notice |
| S087 | 2012-01-24 | Normal 180 Day Track No User Fee |
| S086 | 2012-01-09 | 135 Review Track For 30-day Notice |
| S085 | 2011-12-21 | 30-day Notice |
| S084 | ||
| S083 | 2011-10-24 | 30-day Notice |
| S082 | 2011-10-19 | Normal 180 Day Track |
| S081 | 2011-10-11 | 30-day Notice |
| S080 | 2011-08-30 | 30-day Notice |
| S079 | 2011-08-02 | 30-day Notice |
| S078 | 2011-07-26 | 30-day Notice |
| S077 | 2011-07-22 | Normal 180 Day Track |
| S076 | 2011-07-18 | 30-day Notice |
| S075 | 2011-06-09 | 135 Review Track For 30-day Notice |
| S074 | 2011-06-01 | 30-day Notice |
| S073 | ||
| S072 | 2011-05-09 | 135 Review Track For 30-day Notice |
| S071 | 2011-05-02 | 135 Review Track For 30-day Notice |
| S070 | 2011-04-18 | Normal 180 Day Track No User Fee |
| S069 | 2011-04-13 | 30-day Notice |
| S068 | 2011-04-11 | 30-day Notice |
| S067 | 2011-04-04 | 30-day Notice |
| S066 | 2011-03-30 | 30-day Notice |
| S065 | 2011-03-29 | 30-day Notice |
| S064 | 2011-03-28 | 135 Review Track For 30-day Notice |
| S063 | 2011-03-28 | 30-day Notice |
| S062 | 2011-03-21 | 30-day Notice |
| S061 | 2011-03-18 | 30-day Notice |
| S060 | 2011-02-11 | 135 Review Track For 30-day Notice |
| S059 | 2011-03-04 | 30-day Notice |
| S058 | 2011-02-11 | 135 Review Track For 30-day Notice |
| S057 | ||
| S056 | 2011-02-01 | 30-day Notice |
| S055 | 2010-12-02 | 30-day Notice |
| S054 | 2010-11-26 | Panel Track |
| S053 | 2010-11-15 | 30-day Notice |
| S052 | 2010-11-01 | 30-day Notice |
| S051 | 2010-10-13 | 30-day Notice |
| S050 | 2010-10-12 | 30-day Notice |
| S049 | ||
| S048 | 2010-09-14 | 30-day Notice |
| S047 | 2010-09-07 | 30-day Notice |
| S046 | 2010-09-03 | 135 Review Track For 30-day Notice |
| S045 | 2010-09-02 | 135 Review Track For 30-day Notice |
| S044 | 2010-08-05 | 30-day Notice |
| S043 | 2010-07-27 | 30-day Notice |
| S042 | 2010-07-23 | 30-day Notice |
| S041 | 2010-07-22 | 30-day Notice |
| S040 | 2010-06-23 | 30-day Notice |
| S039 | 2010-06-22 | 30-day Notice |
| S038 | 2010-06-18 | 135 Review Track For 30-day Notice |
| S037 | 2010-05-13 | 30-day Notice |
| S036 | 2010-04-29 | Normal 180 Day Track |
| S035 | 2010-04-23 | 30-day Notice |
| S034 | 2010-04-20 | 30-day Notice |
| S033 | 2010-03-23 | 30-day Notice |
| S032 | 2010-02-01 | 30-day Notice |
| S031 | 2010-01-19 | 135 Review Track For 30-day Notice |
| S030 | ||
| S029 | 2009-11-24 | 30-day Notice |
| S028 | 2009-11-12 | Real-time Process |
| S027 | 2009-10-21 | 30-day Notice |
| S026 | 2009-09-22 | 30-day Notice |
| S025 | 2009-09-21 | 30-day Notice |
| S024 | 2009-09-15 | 30-day Notice |
| S023 | 2009-07-29 | 30-day Notice |
| S022 | 2009-07-21 | 135 Review Track For 30-day Notice |
| S021 | 2009-06-24 | 30-day Notice |
| S020 | 2009-06-03 | 30-day Notice |
| S019 | 2009-06-02 | 30-day Notice |
| S018 | 2009-05-19 | 30-day Notice |
| S017 | 2009-05-01 | 135 Review Track For 30-day Notice |
| S016 | 2009-04-30 | 30-day Notice |
| S015 | 2009-04-13 | 30-day Notice |
| S014 | 2009-03-02 | 135 Review Track For 30-day Notice |
| S013 | 2009-02-26 | 30-day Notice |
| S012 | 2009-02-02 | 30-day Notice |
| S011 | 2009-01-21 | 30-day Notice |
| S010 | 2009-01-14 | Real-time Process |
| S009 | ||
| S008 | 2008-11-17 | 30-day Notice |
| S007 | 2008-11-05 | 30-day Notice |
| S006 | 2008-09-15 | 30-day Notice |
| S005 | 2008-08-21 | 30-day Notice |
| S004 | 2008-08-08 | 30-day Notice |
| S003 | 2008-07-29 | 30-day Notice |
| S002 | 2008-07-18 | Normal 180 Day Track |
| S001 | 2008-07-16 | Normal 180 Day Track |